Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
NCT ID: NCT02514577
Last Updated: 2020-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
217 participants
INTERVENTIONAL
2015-11-07
2017-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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IDP-122 Lotion
Participants will apply IDP-122 Lotion (halobetasol propionate \[HP\] 0.01%) topically once daily for 8 weeks.
IDP-122 Lotion
Topical lotion
IDP-122 Vehicle Lotion
Participants will apply IDP-122 Vehicle Lotion topically once daily for 8 weeks.
IDP-122 Vehicle Lotion
Topical lotion. No active ingredient.
Interventions
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IDP-122 Lotion
Topical lotion
IDP-122 Vehicle Lotion
Topical lotion. No active ingredient.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Freely provides both verbal and written informed consent.
* Has an area of plaque psoriasis appropriate for topical treatment that covers a body surface area (BSA) of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this calculation.
* Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
* Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4 (the face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded from this calculation, if psoriasis is present).
Exclusion Criteria
* Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the Investigator.
* Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the Investigator.
* Is pregnant, nursing an infant, or planning a pregnancy during the study period.
* Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit or is concurrently participating in another clinical study with an investigational drug or device.
18 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Binu j Alexander
Role: STUDY_DIRECTOR
Valeant Pharmaceuticals
Locations
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Valeant Site 11
Hot Springs, Arkansas, United States
Valeant Site 1
Encinitas, California, United States
Valeant Site 10
Encino, California, United States
Valeant Site 12
Santa Rosa, California, United States
Valeant Site 13
Atlanta, Georgia, United States
Valeant Site 7
Boise, Idaho, United States
Valeant Site 6
Rockville, Maryland, United States
Valeant Site 4
Ann Arbor, Michigan, United States
Valeant Site 8
Clarkston, Michigan, United States
Valeant Site 15
Las Vegas, Nevada, United States
Valeant Site 9
Raleigh, North Carolina, United States
Valeant Site 5
Knoxville, Tennessee, United States
Valeant Site 3
Austin, Texas, United States
Valeant Site 2
San Antonio, Texas, United States
Valeant Site 14
Spokane, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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V01-122A-301
Identifier Type: -
Identifier Source: org_study_id
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